A PHASE III/IV, SINGLE ARM, MULTICENTER STUDY OF ATEZOLIZUMAB (TECENTRIQ) TO INVESTIGATE LONG-TERM SAFETY AND EFFICACY IN PREVIOUSLY-TREATED PATIENTS WITH LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER (TAIL) - TAI

F. HOFFMANN-LA ROCHE LTD0 个研究点目标入组 10 人开始时间: 2022年10月18日最近更新: 2024年8月19日

适应症

试验速览

阶段: 3 期
状态: 已完成
发起方: F. HOFFMANN-LA ROCHE LTD
入组人数: 10

研究概览研究设计入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional
分配方式: N/a: Single Arm Study
主要目的: Treatment
盲法: Open (masking not used)

入排标准

年龄范围: 18 至 100（—）
性别: All

入选标准

•Patients must meet the following criteria for study entry:
•1.Signed Informed Consent Form
•2.Age = 18 years
•3.Able to comply with the study protocol, in the investigator’s judgment
•4.Histologically or cytologically documented Stage IIIb or Stage IV NSCLC that has progressed following standard systemic chemotherapy (including if given in combination with anti-PD-1 therapy, after anti-PD-1 as monotherapy, or after TKI therapy). Patients with a previously detected sensitizing EGFR mutation or ALK fusion oncogene must have received targeted therapy (TKI), followed by at least one line of standard systemic chemotherapy, prior to receiving atezolizumab. Overall, patients should not have received more than two lines of standard systemic chemotherapy. Patients who have discontinued first-line or second-line therapy due to intolerance are also eligible
•–Staging must be according to the UICC/AJCC system, 7th edition (Detterbeck et al. 2009) (see Appendix 8)
•–Pathological characterization may be conducted on tumor specimens from earlier stage disease, but the tumor samples must be sufficient to distinguish squamous or non-squamous histology
•–Chemotherapy regimens will be counted based on interval disease progression, and not on the number of agents or the number of switches in agents (e.g., a first-line or second-line therapy that consists of several cycles of a platinum doublet and subsequent maintenance therapy that introduces or switches to a new chemotherapy agent without interval disease progression will all be considered one chemotherapy regimen)
•–Patients with a previously-detected sensitizing EGFR mutation must have experienced disease progression (during or after treatment) on an EGFR TKI (erlotinib, gefitinib, osimertinib, etc.)
•–Patients with a previously detected ALK fusion oncogene must have experienced disease progression (during or after treatment) with crizotinib, alectinib, or another ALK inhibitor
•–Prior radiation therapy is allowed, provided that the patient has recovered from any toxic effects thereof. Combined radiation/chemotherapy treatment constitutes a single regimen
•–Combined radiation/chemotherapy treatment (chemoradiation) counts as one prior chemotherapy regimen if < 6 months have elapsed between the last dose and the date of recurrence
•–Adjuvant/neoadjuvant chemotherapy is not counted as a line of treatment
•–Debulking surgery and anticancer agents used for pleurodesis are not counted as lines of therapy
•5.The last dose of prior systemic anticancer therapy must have been administered = 21 days prior to study treatment initiation
•6.The last dose of prior anti-PD-1 therapy must have been administered
•–Nivolumab must have been discontinued = 14 days and pembrolizumab = 21 days prior to study treatment initiation, providing that these treatments were not administered in a clinical trial setting
•7.Measurable disease, as defined by Response Evaluation Criteria for Solid Tumors, Version 1.1 (RECIST v1.1)
•8.Patients with asymptomatic CNS metastases (treated or untreated), as determined by CT or MRI evaluation during screening and prior radiographic evaluation, are eligible
•9.ECOG performance status 0, 1, or 2 [Appendix 7]
•10.Life expectancy = 12 weeks
•11.Adequate hematologic and end-organ function, defined by the following laboratory results obtained within 2 weeks prior to the first study treatment:
•–Absolute neutrophil count = 1500 cells/µL (without granulocyte colony-stim

排除标准

•Patients who meet any of the following criteria will be excluded from study entry:
•1.Symptomatic CNS metastases
•2.Spinal cord compression not definitively treated with surgery and/or radiation or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for = 2 weeks prior to study treatment initiation
•3.Leptomeningeal disease
•4.Uncontrolled pericardial effusion or ascites requiring recurrent drainage procedures
•5.Pregnant or lactating, or intending to become pregnant during the study
•–Women who are not postmenopausal (postmenopausal defined as = 12 months of non-drug-induced amenorrhea) or surgically sterile must have a negative serum pregnancy test result within 2 weeks prior to initiation of study drug
•6.Evidence of significant uncontrolled concomitant disease that could affect compliance with the protocol, including significant liver disease (such as cirrhosis, uncontrolled major seizure disorder, or superior vena cava syndrome)
•7.Significant cardiovascular disease, such as New York Heart Association cardiac disease = Class III, myocardial infarction within 3 months, unstable arrhythmias, or unstable angina
•–Patients with known coronary artery disease or left ventricular ejection fraction < 50% must be on a stable medical regimen that is optimized in the opinion of the treating physician, in consultation with a cardiologist if appropriate
•8.Significant renal disorder requiring dialysis or indication for renal transplant
•9.Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 28 days prior to study treatment initiation
•10.Major surgical procedure within 4 weeks prior to study treatment initiation or anticipation of need for a major surgical procedure during the course of the study other than for diagnosis
•11.Inability to understand the local language(s) for which the EORTC QLQ-LC13 and EuroQol EQ-5D-5L questionnaires are available (see Appendix 4 for English versions)
•12.History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
•13.Known hypersensitivity or allergy to biopharmaceuticals produced in Chinese hamster ovary cells or any component of the atezolizumab formulation
•14.History of autoimmune disease (Appendix 5) are allowed if controlled and on stable treatment (i.e., same treatment, same dose) for the last 12 weeks, with the exception of:
•–Patients taking concurrent abatacept or belatacept treatment, unless therapy has been withdrawn for > 8 weeks
•–Patients with a history of serious or life threatening immune-related events
•–No more than 1 concomitant autoimmune disease at the time of study entry is allowed unless one of them is:
•Autoimmune-mediated hypothyroidism on a stable dose of thyroid replacement hormone
•Controlled Type I diabetes mellitus on a stable dose of insulin regimen
•A medical history of such entities as atopic disease or childhood arthralgias, where the clinical suspicion of autoimmune disease is low. In addition, transient autoimmune manifestations of an acute infectious disease that resolved upon treatment of the infectious agent are not excluded (e.g., acute Lyme arthritis)
•15.Prior allogeneic stem cell or solid organ transplantation
•16.History of idiopathic pulmonary fibrosis, including pneumonitis, drug-induced pneumonitis, organizing pneumonia (i.e., bronch

研究者

发起方

F. HOFFMANN-LA ROCHE LTD

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